| CTRI Number |
CTRI/2025/07/090379 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of two irrigating Solutions to check the antimicrobial efficacy in primary Teeth |
|
Scientific Title of Study
|
Comparative evaluation of antimicrobial efficacy of sodium hypochlorite with and without etidronic acid as root canal irrigants in primary teeth.
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Amulya.V |
| Designation |
post graduate |
| Affiliation |
The Oxford Dental College Bangalore |
| Address |
The oxford dental collage department of pediatrics and preventive dentistry, room no 8 Bommanahalli, Hosur Road, Bangalore The oxford dental collage department of pediatrics and preventive dentistry room no 8, Bommanahalli, Hosur Road, Bangalore Bangalore KARNATAKA 560068 India |
| Phone |
08748990540 |
| Fax |
|
| Email |
amulya.v685@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Amulya.V |
| Designation |
post graduate |
| Affiliation |
The Oxford Dental College Bangalore |
| Address |
The oxford dental collage department of pediatrics and preventive dentistry room no 8, Bommanahalli, Hosur Road, Bangalore The oxford dental collage department of pediatrics and preventive dentistry room no 8, Bommanahalli, Hosur Road, Bangalore Bangalore KARNATAKA 560068 India |
| Phone |
08748990540 |
| Fax |
|
| Email |
amulya.v685@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Sneharaj N |
| Designation |
reader |
| Affiliation |
The Oxford Dental College Bangalore |
| Address |
The oxford dental collage department of pediatrics and preventive dentistry room no 8, Bommanahalli, Hosur Road, Bangalore The oxford dental collage department of pediatrics and preventive dentistry room no 8, Bommanahalli, Hosur Road, Bangalore Bangalore KARNATAKA 560068 India |
| Phone |
7259784347 |
| Fax |
|
| Email |
dr.sneharaj.n@gmail.com |
|
|
Source of Monetary or Material Support
|
| The oxford dental collage and hospital |
|
|
Primary Sponsor
|
| Name |
Dr Amulya V |
| Address |
The oxford dental collage department of pediatrics and preventive dentistry room no 8, Bommanahalli Hosur Road, Bangalore, India 560068 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| sneharajn |
Bommanahalli oxford dental collage |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| AmulyaV |
The oxford dental college |
Department of pediatric and preventive dentistry,floor no 4 room no 8,The oxford dental college,Bommanahalli, Hosur Road, Bangalore Bangalore KARNATAKA |
08748990540
amulya.v685@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The oxford dental college Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy children requiring endodontic treatment in primary teeth. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
etidronic acid |
Etidronic acid, also known as etidronate or 1-hydroxyethylidene 1,1-biphosphonic (HEBP) is a weak chelator. It can be used to remove inorganic debris. It penetrates deep into the root canals to kill Enterococcus faecalis |
| Comparator Agent |
sodium hypochlorite |
Sodium hypochlorite (NaOCl) is widely used irrigant in the endodontic treatment. It has antibacterial, proteolytic, dissolving and debriding properties. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy children requiring endodontic treatment in primary teeth.
2. Primary teeth with at least two third of total root length remaining.
3. Presence of abscess/soft tissue swelling in relation to the involved tooth.
4. Co-operative children.
5. Spontaneous pain/ pain at night awakening the child at night.
|
|
| ExclusionCriteria |
| Details |
1. Medically compromised children.
2. Children with any recent antibiotic exposure in the preceding 1 months will be excluded from the study.
3. children who have used antimicrobial mouthwashes in the preceding 1 months.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| microbial colonies will be counted using digital colony counter and expressed as colony forming unit (CFU) per millimetre |
1year 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome is to assess the effect of adding etidronic acid on the smear layer removal and dentin integrity during root canal irrigation. This includes evaluating any changes in the structural properties of primary tooth dentin. |
1year 6 months |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Forty children aged 5 to12 years who require endodontic treatment, visiting to the Department of Pediatric and Preventive Dentistry, will be selected for the study who meets the inclusion criteria. The selected children will be divided into two groups of 20 children each: Group I: NaOCl without HEBP. Group II: NaOCl with HEBP. Following administration of local anaesthesia with 2% lignocaine hydrochloride containing adrenaline at a concentration of 1:80000, isolation of the primary molars will be carried out using rubber dam or with cotton rolls in cases do not permit the placement of clamps for rubber dam isolation. Following isolation, the tooth surface, rubber dam and clamp will be cleaned with a solution of 3% (v/v) hydrogen peroxide. The coronal access cavity preparation will be performed using sterile burs (#8 round bur) (Dentsply), and the root canal will be minimally instrumented with K file (Dentsply) and pulp will be extirpated with sterile barbed broach (Dentsply). For each primary molar the largest canal in the upper molar (palatal canal) and lower molar (distal canal) will be selected for the collection of samples from the root canal. The orifice of the remaining canal will be sealed with Cavit (3M ESPE) in order to prevent any possible microbiological contamination during collection of the sample. For each tooth two samples will be collected in order to assess the microbial count. Sample A: after pulp extirpation and before irrigation (baseline). Sample B: after irrigation. A sterile paper point (Metabiomed, India) will be introduced into the full length of the canal and retained in position for 1min to soak up the tissue fluid (sample A).6 The collected sample will be placed in sterile Eppendorf tubes containing a nutrient broth and immediately stored in ice box. The canals will be gently cleaned and shaped. The root canal will be alternatively irrigated with the allotted irrigant to the particular group using sterile syringe with 29-gauge side vented needle (NaviTip) after every step of instrumentation. Sample B will be obtained in the similar manner as described earlier after the irrigation. The treated tooth will be flushed with normal saline to prevent the potential carryover of irrigants. Consequently, a sterile cotton pellet will be placed in the pulp chamber and restored with temporary restoration. The collected samples will be sent to a microbiological laboratory for microbial analysis and microbial colonies will be counted using digital colony counter and expressed as colony forming unit (CFU) per millimetre. The tooth will be subsequently obturated and restored. |